Country · Europe
Pharmaceutical exports to Poland, ready for URPL authorisation
Progene Pharma supplies Polish marketing authorisation holders, importers and wholesalers with generic medicines we manufacture in an EU-GMP and WHO-GMP certified facility. We prepare the CTD dossier, the stability data and the GMP evidence the Office for Registration of Medicinal Products asks for, label in Polish, and ship via Gdańsk and Gdynia.
- Regulator
- URPL
- Labels
- Polish
- Stability
- Zone II, 25 °C / 60% RH
- Main ports
- Gdańsk, Gdynia
The Polish medicines market in brief
Poland is the largest pharmaceutical market in Central and Eastern Europe, with a large population, a strong generics culture and a national reimbursement system. Patients pay a share of the cost of many medicines, so price matters to the doctor and the pharmacist.
A product that is on the reimbursement list sells in far higher volumes, so many manufacturers apply for reimbursement after authorisation. Hospitals buy through tenders, and pharmacies, including large chains, buy from wholesalers.
The authorisation is held by a company established in the EU or EEA, and Polish is the language of labels and leaflets.
Medicines we supply to Poland
These are the medicines Polish distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
-
Generic prescription medicines
Metformin, amlodipine, atorvastatin, losartan and similar generics in tablets and capsules made to the European Pharmacopoeia, for marketing authorisation holders.
-
Generics for the reimbursement list
High-volume active substances such as metformin, amlodipine and atorvastatin, in the packs pharmacies dispense under reimbursement.
-
Antibiotics and anti-infectives
Amoxicillin, amoxicillin and clavulanic acid, azithromycin and ciprofloxacin, and injectable antibiotics for hospitals.
-
Stomach and allergy
Omeprazole, pantoprazole, cetirizine and montelukast, for prescription and pharmacy sale.
-
Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
-
Food supplements
Vitamins, minerals, omega-3, probiotics and protein products for brands selling supplements.
-
Traditional herbal products
Herbal tablets, capsules and powders for the traditional herbal route or for sale as supplements.
-
Cosmetics
Creams, washes, soaps and shampoos with INCI ingredient lists and the data your responsible person needs.
URPL registration, step by step
A medicine cannot be sold in Poland until it has been authorised. This is the usual route for a generic medicine made outside Europe, and the page explains it step by step.
-
01
A local company applies
The authorisation is held by a company established in the EU or EEA, usually the importer or distributor, acting as the marketing authorisation holder. It applies to URPL, or to another EU authority through a shared procedure.
-
02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
-
03
The dossier goes in
The applicant submits the CTD dossier with stability data at Zone II conditions, bioequivalence data where required, the GMP certificate and the product information, in the format the route requires. We prepare the manufacturer's documents.
-
04
URPL reviews it
URPL assesses the dossier, or acts as a reference or concerned authority in a shared procedure, and may ask questions, which we answer with you.
-
05
GMP and batch release
The authority relies on the manufacturer's GMP certificate or inspects the site, and a Qualified Person at the importing site in Europe tests and certifies each batch before it goes on sale.
-
06
Registration and renewal
On approval URPL issues an authorisation with a number, which goes on every pack. The authorisation holder can then apply for reimbursement, and the authorisation is renewed as the rules require.
Registration takes from several months to more than a year, and URPL updates its requirements from time to time, so check the current guidelines with URPL or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Poland
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The URPL application, as the marketing authorisation holder
- The import and wholesale authorisations your business needs
- Bioequivalence studies for generics, where the route requires them
- The Qualified Person who certifies each batch
- Reimbursement and pricing applications
Progene Pharma handles
- The CTD dossier, stability data and bioequivalence data where required
- The EU GMP certificate and the manufacturing details
- The information the Qualified Person needs to certify each batch
- A Certificate of Analysis for every batch
- Labels and leaflets in the product information template, ready for your authorisation number
- Answers to URPL's questions during assessment
Made for Polish conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
-
Polish labels and leaflets
Cartons and patient leaflets in Polish, following the EU product information template, with the authorisation number, batch number and expiry date, and an approved proof before printing.
-
Stability for Europe
Stability studies at 25 °C and 60% relative humidity (Zone II), the condition European authorities ask for, so the shelf life on the pack is valid.
-
Safety features
Braille on the carton and room for the unique identifier and anti-tampering device that prescription medicines carry.
-
Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities pharmacies and hospitals buy.
Shipping to Poland
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Gdańsk and Gdynia
Poland's main Baltic ports, with rail and road freight across the country
-
Via Hamburg or Rotterdam
Some cargo arrives through a North Sea port and continues by road or rail
-
Warsaw
By air to Chopin Airport for urgent orders and samples
-
Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import documents and customs declaration from your side
Where Polish distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Pharmacy chains
Large pharmacy chains buy in volume and sell reimbursed and own-label products.
-
Hospital tenders
Hospitals buy through tenders and ask for the full document set.
-
Wholesalers
Wholesalers supply pharmacies and hospitals across the country.
-
Regional distributors
Distributors also supply neighbouring Central European markets.
Questions about supplying Poland
Something else? Email [email protected].
Do you export medicines to Poland?
Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in Poland.
Can you help us obtain an authorisation from URPL?
Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your Polish company files the application, and we answer URPL's questions with you.
Do I need a local company to hold the authorisation?
Yes. The authorisation is held by a company established in the EU or EEA, usually the importer or distributor. Check the current requirements with URPL.
Which route should we use for Poland?
Poland can authorise a generic nationally, or through the decentralised or mutual recognition procedures that let one assessment serve several EU countries. The right route depends on the product and on where else you plan to sell. Tell us the product and the countries and we will say which fits.
Which documents does URPL ask for?
The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. URPL updates its requirements from time to time, so confirm the current list with URPL or your regulatory consultant. We tell you what we can provide with your quotation.
Who certifies each batch?
A Qualified Person at an authorised importing site in the EU or EEA tests and certifies each batch before it goes on sale. Your importer normally holds that authorisation, and we supply the batch documents the Qualified Person needs. Check the current rules with URPL.
Why does reimbursement matter in Poland?
A reimbursed medicine sells in far higher volumes because patients pay only a share of the price. The authorisation holder applies for reimbursement after authorisation, and we provide the manufacturer's data it needs.
Must the packs be in Polish?
Yes. Labels and leaflets for the Polish market are in Polish, following the EU templates. We prepare the artwork to match your authorisation, and you approve a proof before printing.
What must the packs carry for Poland?
Polish text following the EU product information template, the authorisation number, batch number, expiry date, storage conditions, Braille on the carton and the safety features prescription medicines carry. We prepare the artwork to match your authorisation and you approve a proof before printing.
Are your medicines tested for European conditions?
Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.
Can you supply tenders in Poland?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Poland?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Gdańsk or Gdynia, or by air to Warsaw for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
Related pages
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494